A Multicenter, Randomized, Double-blind, Parallel Design, Active-controlled Phase 3 Study to Determine Efficacy and Safety Following Administration of SMO1 in Patients With Retinal Vein Occlusive Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity (BCVA) at Month 2
研究概览
简要总结
This is a multicenter, randomized, double-masked, parallel-group, active-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of SMO1 (Dexamethasone 700μg intravitreal implant) compared with the reference drug (Dexamethasone 700μg intravitreal implant) in patients with retinal vein occlusion (RVO)-associated macular edema.
Participants are randomized in a 1:1 ratio to receive either the reference drug or the investigational product, SMO1, following screening and baseline assesments. Randomization is centrally managed and stratified by RVO subtype (branch or central). Patients are followed for 6 months with scheduled visits to assess efficacy and safety endpoints. A total of 312 participants (156 per treatment arm) will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years of age or older
- •A study eye diagnosed with macular edema following i) branch retinal vein occlusion (BRVO) within 12 months prior to the screening visit or; ii) central retinal vein occlusion (CRVO) within 9 months prior to the screening visit
- •A study eye with CRT measured to be 300μm or greater using OCT at the screening visit
- •A study eye with BCVA between 34 and 68 letters at the screening visit and the baseline (comparable to Snellen score between 20/200 and 20/50)
- •Provided written informed consent voluntarily after receiving a full explanation of the clinical trial
排除标准
- •A study eye with visual improvement determined to be highly unlikely due to the baseline condition of the eye
- •A study eye with macular edema caused by the formation of an epiretinal membrane or visual improvement determined to be highly unlikely even if the macular edema decreases
- •A study eye with uncontrolled glaucoma with intraocular pressure of 25mmHg or higher despite medical treatment at the screening visit
- •A study eye with severe media opacity such as corneal opacity, cataracts, or vitreous hemorrhage
结局指标
主要结局
Best corrected visual acuity (BCVA) at Month 2
时间窗: Month 2
Change in BCVA score from the baseline, at Month 2 after the administration of the investigational drug using early treatment diabetic retinopathy study (ETDRS) chart
次要结局
- BCVA at Month 1, 3, and 6(Month 1, 3, and 6)
- BCVA improvement of 15 letters (3 lines) or more(Month 1, 2, 3, and 6)
- Central retinal thickness (CRT) at each visit(Month 1, 2, 3, and 6)